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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Fosamax (2011)

Εκδότης

Εκδότης Merck Sharp & Dohme Limited
Διεύθυνση Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Περιεχόμενα

Name of the medicinal product

FOSAMAX® 10 mg Tablets.

Qualitative and quantitative composition

Each tablet contains 13.05 mg of alendronate sodium, which is the molar equivalent to 10 mg of alendronic ...

Pharmaceutical form

Tablets. Oval white tablets marked with 936 on one side, and plain on the other.

Therapeutic indications

Fosamax is indicated for the treatment of osteoporosis in post-menopausal women to prevent fractures. ...

Posology and method of administration

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need ...

Contraindications

Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture ...

Special warnings and precautions for use

Fosamax can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential ...

Interaction with other medicinal products and other forms of interaction

If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, ...

Pregnancy and lactation

Use during pregnancy Alendronate should not be used during pregnancy. There are no adequate data from ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines has been performed. However, certain ...

Undesirable effects

Fosamax has been studied in nine major clinical studies (n=5,886). In the longest running trials in post-menopausal ...

Overdose

No specific information is available on the treatment of overdosage with Fosamax. Hypocalcaemia, hypophosphataemia ...

Pharmacodynamic properties

Fosamax is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone ...

Pharmacokinetic properties

Absorption Relative to an intravenous (IV) reference dose, the oral bioavailability of alendronate in ...

Preclinical safety data

In test animal species the main target organs for toxicity were kidneys and gastro-intestinal tract. ...

List of excipients

10 mg tablets: Microcrystalline cellulose Anhydrous lactose Croscarmellose sodium Magnesium stearate ...

Incompatibilities

None known.

Shelf life

3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Blisters of opaque white PVC lidded with aluminium foil. Pack size: 28 tablets.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU UK

Marketing authorization number(s)

10 mg tablets: PL 0025/0326

Date of first authorization / renewal of the authorization

10 mg tablets: 28 July 1995/ 3 June 2008

Date of revision of the text

December 2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.